UM hosts symposium on next generation characterization tools for therapeutic proteins

In a concerted effort to boost regional collaboration on developing new protein drug and diagnostics, the University of Maryland (UM) School of Pharmacy has hosted the first Interdisciplinary Symposium on Next Generation Characterization Tools for Therapeutic Proteins.

The symposium was cosponsored by the pharmaceutical standards group U.S. Pharmacopeial Convention (USP) and the National Institute of Standards and Technology along with the University of Maryland, College Park.

More than 100 senior protein researchers converged on the School from industry, government agencies, and universities in the mid-Atlantic region and participated in three extensive brainstorming sessions. The sessions provided virtual blueprints for merging their work into future collaborations. The aim was to speed up completing and marketing a widening pipeline of protein applications now emerging from the human genome data.

The essence of the brainstorming was perhaps well illustrated by a single human gene discovered in 1990 by presenter John Herr, PhD. Antibodies that bind to that SP-10 gene discovered by Herr are the basis for a new home test, SpermCheck Vasectomy, on drug store shelves for monitoring sperm after vasectomy. Herr, a professor at the University of Virginia School of Medicine, said that many more protein-based products "are just now starting to bubble up."

Global markets are on the rise for the different types of drugs and medical tests called biologics that are based on proteins including insulin, cytokines, bioengineered antibodies, enzymes, hormones, coagulants, interferon's, growth factor proteins, and interleukins. Protein drugs are increasingly important, according to symposium presenters, because of the advent of high-tech laboratory molecular screening and protein mapping, while the list of medical conditions amenable to biologics ̶ including hemophilia, diabetes, cancer, cystic fibrosis, hepatitis, psoriasis and congenital diseases ̶ is also growing rapidly.

Herr said that as scientists further characterize the annotated ̶ or yet-to-be described ̶ part of the genome, one protein at a time, "We are opening up a new field of enormous promise."

"The first draft of the human genome was completed only 10 years ago. You are just now going to start seeing the careful fruit of all this good cell biology beginning to be manifested," said Herr. The future holds promise for better diagnostics of cancer, early detection of diseases and many new therapeutics.

"I discovered that gene 20 years ago, so the issue is that from discovering a novel gene, characterizing its proteins, understanding its biology, conceiving its application, getting it into industry, getting through the FDA is a very long process for a biological [product]," said Herr.

Edith Chang, PhD, a USP reference standards scientist, spoke of an explosion of knowledge regarding the structures and functions of proteins for biologic therapies. "We know that in 10 years, we will have to pick up those technologies. For us [USP] it is important to look into the future to see what technologies there will be for biologics because it is coming our way," she says.

Chang said the USP organizers recently toured the UM School of Pharmacy in Baltimore. "We saw that this is a really good facility and great faculty, and we wanted this symposium to be an academia driven-type of collaboration. We really want to push this local area for research collaboration with a goal of as much collaboration as there is in San Diego and Boston. This could be the first of many more such meetings."

Keynote speaker Charles Craik, PhD, (pictured above) professor of pharmaceutical chemistry at the University of California, San Francisco, opened the symposium with an optimistic look at a wide open field of using proteases, which are powerful but common enzymes in the body. He said proteases can be safe and effective therapeutics for such conditions as bleeding disorders and sepsis. Currently there are 12 Food and Drug Administration approved protease therapies.